Method and connection unit for sterile transfer of solution via a connector

ABSTRACT

Methods for the sterile transfer of a solution are disclosed, including sterilizing the inlet to a connector by flowing a sterilizing fluid around the connector inlet, sterilizing a penetrating element for the connector by flowing a sterilizing solution around the penetrating element, and penetrating the sterilized inlet by the sterilized penetrating element in order to transfer the solution through the penetrating element on the connector. Apparatus for such sterile transfer of a solution is also provided.

This application is a continuation of U.S. application Ser. No.08/793,349 filed Feb. 20, 1997, which is a 371 of PCT/SE95/00795 filedJun. 28, 1995.

FIELD OF THE INVENTION

The present invention relates to a method and a connection unit for thesterile transfer of solution through a connector.

BACKGROUND OF THE INVENTION

The present invention is intended to be used in conjunction with anon-line sterilizing arrangement, such as described European ApplicationNo. 428,009. This application describes a continuous heat sterilizingarrangement in which a solution is heated during transport in a conduitto a high temperature, for example about 130° C., and is maintained atthis temperature for a predetermined period in order to effectsterilization. Thereafter, the solution is cooled to the temperature atwhich it is to be used. The sterilization step takes place at a highpressure, which is achieved with a pump and throttle arrangement.

A heat exchanger is generally used in this system to provide the heatenergy. The sterilization arrangement is used for sterilizing infusionsolutions such as Ringer's solution, other medical solutions such asdialysis solutions, purified water to obtain sterilized water, or othersuch solutions.

The sterilizing arrangement according to European Application No.428,009 is provided with a shunt conduit which in principle connects theinlet to the outlet so that the solution which is in the system can becirculated in a closed circuit. In this manner, the temperature of thecirculating solution can be raised to, for example, 120° C. in order tosterilize the device itself.

The solution which has been sterilized with the above-describedsterilizing arrangement can be used directly, for example in dialysis orinfusion. In certain circumstances it is also desirable to transfer thesterilized solution to storage bags for later use, or for delivery toother departments within the hospital. For this purpose, disposable setsof tubes are available which terminate with a bag.

Normally, such bags are filled with a medical solution, whereafter theset of tubes is sealed and the disposable article is then sterilized inits entirety, i.e. with the medical solution within the bag. Suchsterilizing can be effected with gamma-sterilization or by means ofautoclaving.

Alternatively, the set of tubes can be provided with a medical solutionafter the set of tubes has been sterilized. In such cases, a sterileconnector is normally used which comprises a membrane which is brokenwhen used. Those parts which are connected together are sterile. Withsuch a sterile connector, there is always the risk that bacteria whichmay reside on the outer side of the membrane are introduced with theconnector device and contaminate the interior of the connector.

European Application No. 230,864 describes a sterile connection of twocontainers in which the connection takes place in a sterilized chamberwhich is maintained under aseptic conditions by means of a chemicaldisinfectant. Chemical disinfection, however, does not guaranteesterility, and at the same time the risk for bacteria contamination isstill present.

SUMMARY OF THE INVENTION

In accordance with the present invention, these and other objects havenow been realized by the invention of a method for the sterile transferof a solution from a first location associated with a penetratingelement to a second location through a connector having an inlet, themethod comprising sterilizing the inlet of the connector by flowing asterilizing solution around the inlet of the connector, sterilizing thepenetrating element by flowing a sterilizing solution around thepenetrating element, and penetrating the sterilized inlet by thesterilized penetrating element so as to transfer the solution from thefirst location to the second location through a connector.

In accordance with one embodiment of the method of the presentinvention, the sterilizing of the inlet of the connector and thesterilizing of the penetrating element both comprise heat sterilizing.Preferably, the heat sterilizing is carried out at a temperature ofgreater than about 120° C. Most preferably, the heat sterilizing is alsocarried out at a pressure of greater than about 2 atmospheres (absolutepressure).

In accordance with another embodiment of the method of the presentinvention, the sterilizing of the inlet of the connector and thesterilizing of the penetrating element are carried out simultaneously byuse of the same sterilizing solution. In a preferred embodiment, themethod includes maintaining the penetrating element and the inlet of theconnector within a common bore, and circulating the sterilizing solutionin a closed circuit including a heater for the sterilized solution. Mostpreferably, the method includes sterilizing the common bore and sealingat least a portion of the sterilized common bore with the inlet of theconnector during the penetrating step.

In accordance with the apparatus of the present invention, apparatus isprovided for the sterile transfer of a solution from a first locationassociated with an inlet to the apparatus to a second location through aconnector having an inlet, the apparatus comprising a housing defining abore in fluid communication with the inlet, the connector beinginsertable into the bore, a penetrating element disposed within thebore, recirculation means for recirculating a sterilizing solutionaround the penetrating element and the inlet of the connector locatedwithin the bore, and activation means for causing the penetratingelement to penetrate the inlet of the connector within the bore wherebythe solution can be transferred from the first location to the secondlocation.

In accordance with one embodiment of the apparatus of the presentinvention, the apparatus includes sealing means for sealing a portion ofthe penetrating element and the inlet of the connector sterilized by thesterilizing solution. In a preferred embodiment, the sealing means alsoacts to seal the recirculation means when the activation means causesthe penetrating element to penetrate the inlet of the connector, therebycreating a closed sterilized region.

In accordance with another embodiment of the apparatus of the presentinvention, the apparatus includes heating means for heating thesterilizing solution to a temperature of greater than about 120° C. In apreferred embodiment, the apparatus also includes pressure means forincreasing the pressure of the sterilizing solution to a pressure ofgreater than about 2 atmospheres (absolute pressure).

In accordance with another embodiment of the apparatus of the presentinvention, the sealing means comprises a cover over the inlet of theconnector, whereby the penetrating element penetrates the cover when theactivation means causes the penetrating element to penetrate the inletof the connector.

The object of the present invention is to provide both a method and aconnection unit which permit sterile connection for transfer of asterilized solution to a previously sterilized disposable set of tubesin a manner such that bacterial contamination is completely eliminated.The set of tubes can end with a connection bag, or may lead to aninfusion device or a dialysis machine or other medical equipment.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described in greater detail in the followingdetailed description, which includes reference to the embodiments of theinvention shown in the drawings, in which:

FIG. 1 is a schematic representation of the sterilizing arrangementaccording to European Application No. 428,009;

FIG. 2 is a representation similar to that of FIG. 1, showing, however,the connection of a connecting unit according to the present inventiontherein;

FIG. 3 is a side, elevational, cross-sectional view of the connectionunit of the present invention, in a stand-by position;

FIG. 4 is a side, elevational, cross-sectional view of a connectorintended to be used in accordance with the present invention;

FIG. 5 is a top, plan view of the connector according to FIG. 4;

FIG. 6 is a side, elevational view similar to that of FIG. 3, showingthe connection unit of the present invention in an open position forintroduction of the connector according to FIG. 4 therein;

FIG. 7 is a side, elevational view similar to that of FIG. 6, showingthe connection unit of the present invention with in situ connector in asterilizing position;

FIG. 8 is a side, elevational view, similar to that of FIG. 6, showingthe connection unit of the present invention in a filling position;

FIG. 9 is a side, elevational, cross-sectional view similar to that ofFIG. 3, showing the connection unit of the present invention in anotheradaptation;

FIG. 10 is an enlarged, partial, side, cross-sectional view of a portionof the connection unit of the present invention according to analternative embodiment threof; and

FIG. 11 is a side, elevational, partially cross-sectional view, similarto that of FIG. 3, showing a further adaptation of the connection unitof the present invention.

DETAILED DESCRIPTION

A sterilizing arrangement according to European Application No. 428,009is shown in FIG. 1. A solution which is to be sterilized is introducedthrough inlet 5 and flows through a valve 12 to a pump 8. The pump 8increases the pressure of the solution and pumps the solution to a firstheat exchanger 2.

The solution passes across the primary side of the heat exchanger 2 andis fed to a heating arrangement 3. The solution is transported from theheating arrangement 3 in a delay conduit 15 of a length such that theresidence time permits sterilizing of the solution which has been heatedby the heating arrangement 3.

The solution is then fed from the conduit 15 to the heat exchanger 2where the solution passes across the secondary side of the heatexchanger and heats the incoming solution on the primary side.

The solution is transported from the heat exchanger 2 to a second heatexchanger 6, and passes across its primary side. A heating medium isprovided on the secondary side of the heat exchanger 6, which heatingmedium can be cold water if further cooling is required, and which flowsfrom an inlet 10 to an outlet 11. The solution flows from the heatexchanger 6 by means of a throttle arrangement 7 and a valve 13 to anoutlet 9.

A shunt conduit 14 is connected between the inlet 5 downstream of thevalve 12 and the outlet 9 upstream of the valve 13. The function of theshunt conduit 14 is to allow recirculation of the solution in the systemwithout any new solution being introduced through the inlet 5 or removedby the outlet 9. By shutting off the cooling means supply to the secondheat exchanger 6, the solution in the closed circulating system can beheated to a high temperature, for example 120° C., for sterilizing thesystem.

In addition, a bleed valve 4 is arranged downstream of the throttlevalve 7 and upstream of the outlet valve 13.

The connection unit 20 according to the present invention is arranged incooperation with the shunt conduit 14 and shown in FIG. 2. Theconnection unit has an inlet 21 for incoming solution from the throttlevalve 7, an outlet 23 for solution which is to be recirculated in theshunt conduit 14 and an outlet 22 for exiting sterile solution.

In FIG. 3, the connection unit 20 according to the present invention isshown in a stand-by position. The connections of the various conduitsaccording to FIG. 2 are shown in FIG. 3. Accordingly, there is an inlet21 (positioned behind the unit 20 in FIG. 3) which is connected to thethrottle valve 7 and the bleed valve 4. In addition, there is an outlet23 to the shunt conduit 14. A piston 19 is shown in a closed positionand closes the opening 22 which will be explained in greater detailbelow.

The inlet 21 opens into a cylindrical bore 25 through a tube 26 which isconcentric with the bore 25 and which terminates with a penetrationelement in the form of a point 27. Solution from the throttle valve 7can thus be fed through the inlet conduit 24 to the inlet 21 andsubsequently to the tube 26 and, through the point 27, into the bore 25and further through the outlet 23 to the shunt conduit 14.

In FIG. 3, the bore 25 is sealed at its upper end by the piston 19 whichcooperates with an O-ring seal 28 arranged in the side of the bore.

The operation in the stand-by position as shown in FIG. 3 thus permitsthe sterilizing arrangement according to European Application No.428,009 to be used with recirculation according to the presentinvention.

When the connection unit 20 is to be used for filling of a disposableset of tubes, a connector 30 as shown in FIGS. 4 and 5 is used. FIG. 4is a cross-sectional view taken through the connector. The connectorconsists of a cylinder 31 of a diameter such that it fits in the bore 25and seals against the O-ring 28. At the lower region of the cylinder 31there is a reduced portion 32 on which a cover 33 is arranged. The cover33 can be of rubber. In addition, the connector 30 has asemi-cylindrical-shaped engagement portion 34 of such dimension that thepiston 19 fits therein. Finally, a connection portion 35 is provided towhich a tube is connected. The tube leads to a container which is to befilled or some other suitable device, such as a dialysis machine. InFIG. 5, the connector 30 is seen from above.

The connection unit according to the present invention can be used tofill a container connected to the connector 30. This takes place in thefollowing manner (see FIGS. 6-8). Firstly, it is assured that theconnecting unit is depressurized by means of opening the bleed valve 4.Thereafter, the piston 19 is displaced by means of an activating device36, to the position shown in FIG. 6. By means of this displacement ofthe activating device 36, an opening 22 is revealed in the side of theconnection unit which leads to a cavity 27. The bore 35 opens into thiscavity. Accordingly, the opening to the bore 25 is exposed.

The connector 30 is introduced through the opening 22 so that the lowerregion 32 is located immediately above the bore 25 and can be downwardlydisplaced into the bore 25 so that the cylinder 31 cooperates with theO-ring 28. This position is shown in FIG. 7.

The correct introduction of the connector into the bore 25 isfacilitated by means of the engagement portion 34 cooperating with thepiston 19 and snap fastening therewith during the insertion of theconnector 30 through the opening 22. Thereafter, the activating deviceis displaced downwardly to the position shown in FIG. 7.

As is evident from FIG. 7, the connector 30 is only partially introducedinto the bore 25. The connector 30 is introduced into the bore 25 by adistance such that the O-ring 28 cooperates with the cylindrical surfaceof the connector 30 so that sealing of the bore 25 is achieved. At thesame time, the connector 30 is so high up that the point 27 does notreach the cover 33 on the connector 30.

The sterilizing arrangement according to FIG. 2 has a particularsterilizing position in which the solution is heated to a hightemperature, for example 120° C. This is achieved by means of cold waterno longer being supplied to the secondary side of the second heatexchanger 6, and the heating arrangement 3 being operated so that thetemperature in the recirculating system increases to 120° C. In thismanner, the pressure in the entire circulation conduit rises to apressure of about 2 atmospheres (absolute pressure, i.e. an overpressureof one atmosphere). This pressure arises automatically, since the valves12 and 13 are closed.

In the position shown in FIG. 7, the sterilizing arrangement isactivated so that a solution with a temperature of about 120° C.circulates through the conduit 24, inlet 21, tube 26 and point 27 to thebore 25, and may flow around the cover 33 of the connector 30, andfurther through the outlet 23 to the shunt conduit 14 as describedabove. This position is maintained for as long as it requires for thebore 25 and the lower portion of the connector 30 to become sterilized.

When a sufficiently long period of time has elapsed for thesterilization to have been achieved, the drainage valve 4 is activatedand the sterilizing arrangement is adjusted so that solution which is tobe sterilized is introduced through the inlet 5, and is allowed to flowthrough the system. For this to occur, the shunt conduit 14 is closed bymeans of the valve 29 (see FIG. 3). The bleed valve 4 is open untilnormal operation is attained in the system.

When normal operation is attained, the activating device 36 is activatedto press the connector 30 downwardly to its lower position as shown inFIG. 8 at the same time that the valve 4 is closed. In this position,the point 27 penetrates the cover 33 so that access is gained to theinterior of the connector. At the same time, the outer peripheralportions of the cover 30 seal against the base of the bore so that theoutlet 23 is closed off. In this manner, all solution which entersthrough the inlet 21 has to flow into the connector 30 and to aconnected storage bag or dialysis machine or other medical equipment.

By means of this embodiment of the connecting unit hereof, the outerportion of the connector 25 and the point 27 are sterilized before thesetwo parts cooperate with each other. In this manner, the risk ofbacteria entering the connector 30 when the cover or membrane 33 ispenetrated is totally eliminated.

When filling of a storage bag is completed, the bag is sealed in asuitable manner, for example by means of heat welding in a known manner.

It is also possible to make the cover 33 of a rubber material providedwith slots which seal in a sterile manner after removal of the point 27.Such a connector is previously known from European Application No.116,986.

As has been previously mentioned, the sterilizing solution is heated toa high temperature, for example about 121° C. The pressure in the bore25 thus becomes about 2 atmospheres. In order to assure sterility, it isnecessary that circulation continues for about 20 minutes.

It may be desirable to reduce this time, and this can be achieved byincreasing the temperature to, for example, 130° C. and a pressure of2.7 atmospheres. In this manner, the time can be reduced to about twominutes. It must be ensured, however, that the hot sterilizing solutionreaches all the regions which are to be sterilized.

As is apparent from FIG. 3, the cover 33 is provided with a depressionin which the point 27 is positioned during the sterilizing cycle. Theregion which must be sterilized is this depression as well as the regionof the cover which forms the seal against the base of the bore 25. Inaddition, the actual penetrating part 27 must be sterilized. Aneffective sterilizing at high temperature can be attained if the point27 is shaped as a cone provided with a plurality of small holes. Thesterilizing solution will thus spray the inside of the depression of thecover 33 which will thereby be intensely treated with sterilizingsolution.

It is preferred that the cover 33 be made from a material whichtolerates high temperatures up to at least about 150° C. The remainingpart of the connector 33 can be more or less effectively insulated fromthe warm sterilizing solution, for example by means of the cover 33,which extends a certain amount upwardly along the cylindrical outersurface of the connector.

The connection unit according to the present invention can of course beused independently of the sterilizing arrangement, as is apparent fromEuropean Application No. 428,009. Thus, an arrangement can be used asshown in FIG. 9. The sterile solution which is to be transferred to acontainer through the connector 30 is fed through a conduit 41 and anon-return valve 42. A pump 43 feeds the sterile solution in the conduit41 to the inlet 21. When the connection unit is in the sterilizingposition shown in FIG. 9, the solution which is introduced through theconduit 21 has to flow out through the outlet 23 to the shunt conduit44. The shunt conduit 44 extends through a heating arrangement 45 backto the inlet of the pump 43.

When the pump 43 is actuated, the solution circulates in a closedcircuit through the inlet 21 and the bore 25 to the outlet 23 by meansof the shunt conduit 44 and the heating arrangement 45 back to the pump43. No further solution can be introduced through the inlet 41.

When the cover 33 of the connector 30 and the bore 25, as well as thepenetrating element 27, are to be sterilized, the heating arrangement 45is activated and heats the solution which circulates in the circuit to atemperature of about 120° C. The pressure in the circulating solutionrises but because of the non-return valve 42 the solution does not boil.When the solution has circulated at 120° C. for a sufficiently longtime, for example about 20 minutes, the heating arrangement 45 isdisconnected and the still circulating solution is allowed to cool. Whena sufficiently low temperature has been attained, which is measured by atemperature sensor 46, the activating device 36 is activated to pressthe connector 30 to the position shown in FIG. 8. The temperature atwhich this activation occurs is dependent on the material of theconnector 30. If PVC-material is used, it is preferred that thetemperature has decreased to at least about 80° C. Measurements canalternatively be carried out using a pressure sensor 48, possibly incombination with the temperature sensor 46.

When the connector 30 is pushed down to its bottom position, the cover33 seals the outlet 23 so that the circulation in the conduit 44 ceases.The pump 43 continues to operate and thereby draws solution from theconduit 41 through the non-return valve 42 and feeds the solutionthrough the inlet 21 and the connector 30 to a storage bag or the likeconnected to the connector 30.

The sterilizing of the penetrating member 27 and the connector 30 cantake place using the sterile solution which is introduced through theconduit 41, and which is heated with the heating arrangement 45.

Alternatively, pure water can be circulated in the circulation circuit44. When the sterilizing is completed, a valve 47 is adjusted which isshown with dashed lines in FIG. 9 and the contents of the pump 43, theinlet 21, the bore 25 and the outlet 23 can pass to an outlet at thesame time as the sterile solution which is to be fed in passes throughthe conduit 41, the pump 43, the inlet 21 and to the bore 25 and furtherthrough the outlet 23. At the same time, the pressure drops to aboutatmospheric pressure. When a sufficiently long time has expired for allthe water to have been replaced, the activating device 36 is activatedso that filling is initiated.

An alternative embodiment of the bore 25 is shown in FIG. 10. Thus, thebore is provided with a lower expansion 51. In this manner, thesterilizing solution will circulate around the entire lower portion ofthe connector 30 so that it becomes sterilized. This embodiment issuitable if the connector 30 is made from a material which toleratestemperatures in the order of about 120° C. without deformation, such aspolycarbonate.

Furthermore, the penetrating element 52 is provided with a conicalregion 53 which, when activation of the activating device and downwarddisplacement of the connector 30 take place, cooperates with the coveror seal 33 of the connector at the same time that cooperation occurswith the base of the bore. In this manner, the region which must besterile to allow sterile transfer to be able to take place is furtherrestricted.

In order to facilitate the recirculation, the conical region 52 isprovided with a plurality of holes 54 so that the sterilizing solutioncan flow through the tip 55 of the penetrating element as well asthrough the opening 54. In this manner, a larger circulation flow ismaintained during the sterilizing phase.

Two outlets 56 and 57 corresponding to the outlet 23 are shown in FIG.10. These outlets can be tangentially arranged to ensure the best flowproperties in the bore 25. It is also possible to use the conduit 56 asan inlet as well as the inlet 52 in order to further increase the flow.Further variations will be apparent to a skilled person. A furthervariant of the present invention is shown in FIG. 11, which can be usedto connect a bag containing sterile solution to a machine in which thesterile solution is to be used, for example a dialysis machine or aninfusion tube.

The sterile solution is in a storage bag or a device which is connectedby means of a connector 30 shown on the left in FIG. 11. The connector30 is connected to a connector 35 of a user who is to use the sterilesolution. The two connectors 30 and 30′ are each inserted in respectivebores 25 and 25′ with respective points 27 and 27′. The bores 25 and 25′are connected to each other by means of a communication passage 61.During the sterilizing phase, a solution, which can be water, iscirculated by the pump 8 to the tip 27′, around the cover 33′, into thebore 25′ and through the communication passage 61 to the other bore 25,further around the cover 33, to the point 27 and by means of the heatingarrangement 3 back to the pump 8. By activating the heating arrangement3, the circulating solution is heated to about 121° C. In this manner,an inner pressure of about 2 atmospheres is reached. When the thusinitiated sterilizing has gone on for about 20 minutes, a valve 62 isswitched before the pump 8 to its second position so that the heatingarrangement 3 is by-passed by the conduit 63. The circulation continuesuntil the temperature which is sensed by a temperature sensor 64 hasfallen to a safe temperature, for example about 60° C.

The second bore 25′ is connected to a valve 66 and a flexible storagebag 67 through a conduit 65.

When the temperature has dropped to a suitable level, the activatingdevice 36 is activated on the left-side connector 30 and presses theconnector 30 down to its lower position. This causes the point 27 topenetrate the cover 33 and the cover 33 seals the passage 61 and thebore 25. A sterile connection between the connector 30 with the point 27has thus been attained.

The sterile solution which is supplied by the connector 30 flows throughthe point 27, the conduit 63, the valve 62 and the pump 8 to the point27′. The solution flows from the point 27′ further to the bore 25′.Since the conduit 61 is closed at its left end by means of the cover 33,the solution cannot pass through the conduit 61. Instead, the solutionflows through the conduit 65 through the now open valve 66 to thestorage bag 67.

When a sufficient quantity of sterile solution has flowed along thispath and has displaced all solution which has been used for sterilizing,which occurs after approximately one minute, the activating device 36′is activated and connects the connector 30′ with the point 27′ whichpenetrates the cover 33′ which simultaneously seals against the base ofthe bore 25′. In this manner, the conduit 25 is sealed off whereby thevalve 66 can be closed. A sterile connection between the connector 30and the connector 30′ has now been attained.

In the embodiment of the connection unit which is shown in FIGS. 3-9,the bore 25 is preferably arranged in a heat-insulating material such aspolycarbonate. In this manner, the regions of the connector 30 above thecover 33 are prevented from being heated to a great degree during thesterilizing phase. This makes it possible for cheap material for theconnector 30, such as PVC, to be used without the risk of deformationduring the sterilizing phase.

The sterile solution can be infusion solutions, dialysis solutions orother medical solutions such as physiological sodium chloride solution,and the like.

The sterile solution can also be water, which is filled in bags throughthe connector. The bags contain a salt in powder form and are sterilizedby suitable means so that the interior of the connector, the bags andtheir contents are sterile. When the bags are to be used, they areconnected to the sterilizing arrangement 1 according to FIG. 2 and wateris added to the bags. In this manner, the salt is dissolved and amedical solution is provided ready for use. The salt can contain severalsubstances, such as a concentrate which is used in hemodialysis. Thesalt can also contain further substances, such as medically activesubstances in connection with infusion.

Suitably, the sterile solution itself is also used for the sterilizingphase. That portion of the sterile solution which has been used forsterilizing can be disposed of and new sterile solution used for fillingthe connector.

As has been mentioned above, a particular solution such as physiologicalsodium chloride solution or water can be used for the heat-sterilizingphase of the connector's outer portion, whereafter the solution isdisposed of and replaced by the sterile solution which is to be added tothe connector, such as dialysis solution, peritoneal dialysis solution(containing i.e. glucose) infusion solution, and the like.

The invention is not restricted to the above-described embodiment butcan be modified within the scope of the invention in a manner obviousfor the skilled person. The various described components can be combinedin other ways than those which have been shown in the drawings.

What is claimed is:
 1. Apparatus for the sterile transfer of a solutionfrom a first location to a second location, said apparatus comprising ahousing having an inlet in fluid communication with said first location,a sterilizable connector having an inlet for insertion into and removalfrom said housing, recirculation means for recirculating a sterilizingsolution into said housing through said housing inlet for sterilizingsaid housing inlet of said sterilizable connector inlet when saidsterilizable connector is inserted into said housing and in order tosupply said solution to said second location through said sterilizableconnector, and heating means for heating said sterilizable solution to atemperature of greater than about 120° C.
 2. The apparatus of claim 1wherein said housing includes a bore in fluid communication with saidhousing inlet, whereby said sterilizable connector can be inserted intosaid bore and said recirculation means also sterilizes said bore.
 3. Theapparatus of claim 1 including pressure means for increasing thepressure of said sterilizing solution to a pressure of greater thanabout 2 atmospheres (absolute pressure).
 4. The apparatus of claim 2wherein said sterilizable connector includes a closed penetrable portionfor insertion into said housing, whereby said sterilizable connector issealed from the atmosphere when inserted into said bore.
 5. Theapparatus of claim 1 wherein said housing includes a sterile solutionoutlet for insertion of said sterilizable connector thereinto.
 6. Theapparatus of claim 4 wherein said bore includes an O-ring, whereby saidsterilizable connector seals against said O-ring upon insertion intosaid bore.
 7. The apparatus of claim 1 wherein said housing includes anoutlet, and said recirculation means circulates said sterilizablesolution through said outlet for return to said inlet.
 8. Apparatus forthe sterile transfer of a solution comprising a housing having an inletand containing a penetrating member, a sterilizable connector having aninlet for insertion into said housing to a predetermined positionadjacent to said penetrating member and an outlet, said inlet includinga penetrable seal for sealing said sterilizable connector from theatmosphere, circulation means for circulating a sterilizing solutioninto said housing to said predetermined position whereby saidsterilizing solution can sterilize said penetrating member and saidinlet of said sterilizable connector, and means for causing saidpenetrating member to penetrate said penetrable seal, whereby saidsterilizing solution can flow through said sterilizable connector.